Summary Hospital Adverse Event Reports - Oregon State Library

Bethany Higgins Administrator

Leslie Ray PhD, RN Patient Safety Consultant

Sydney Edlund Data Analyst

April 2011

2010 Summary Hospital Adverse Event Reporting

Message from the Administrator

This year, Oregon hospitals began their sixth year of adverse event reporting. Oregonians can be proud

of our hospitals’ work in identifying, investigating and reporting adverse events. In particular, your

hospital’s willingness to participate in this reporting program underlines your commitment to patient

safety and demonstrates to the public that your organization is committed to safe care.

To create lasting improvements, however, we must commit to transparency in reducing preventable

injury and harm. To build a true safety culture, we must learn from -- and capitalize on -- opportunities

to identify and correct underlying system issues that lead to adverse events. Oregon is unique in its

voluntary reporting system; this strength can be preserved by your full participation in transparency and

reporting.

Please consider the Commission as your partner in patient safety; we are committed to providing

resources and support so you can give your patients the high-quality, reliable and safe care they depend

upon. Support that we offer includes:

1. Guidance through the adverse event reporting process, supporting and strengthening

your root cause analyses;

2. Recommendations and access to quality improvement tools, based on needs identified

through the reporting program;

3. Meaningful feedback – individualized to your hospital, and in aggregate to all Oregon

hospitals -- helping promote awareness and prevent recurrence of similar problems;

4. A monthly newsletter that offers evidence-based resources and references to the latest

patient safety news.

The following summary of adverse event reports submitted in 2010 serves two purposes. First, it

provides statewide information on the adverse events themselves. Second, and perhaps more

importantly, the 2010 data suggest a method to judge overall progress toward robust reporting. At the

same time, we are committed to decreasing the administrative burden of reporting and are embarking

upon a redesign process over the summer to optimize the reporting tool.

We are setting annual reporting goals for 2011 through 2015. These goals outline incremental targets

and standards for quantity, quality and timeliness for both submissions and written notification. To

develop these standards, we reviewed previous reporting trends and utilized some of the latest

evidence related to volume of adverse events in hospitals. We then set achievable annual targets

customized to your hospital, based on volume of discharges. For a more complete description of this

Alone we can do so little; together we can do so much.

Helen Keller

effort, please see the document entitled Progress toward Robust Reporting, which describes these goals

in more detail.

Leslie Ray is your contact at the Commission for the hospital adverse event reporting program

(503.224.9227 or [email protected]). Please call or email Leslie with any questions

regarding this report or comments regarding our new reporting standards for 2011-2015. Together, we

can achieve Oregon’s North Star Goal, creating the safest healthcare delivery system in the country. We

welcome your thoughts as to how we can best support you in the coming year.

Sincerely,

Bethany A. Higgins

Administrator


[iii]

Executive Summary _______________________________________________ v

Characteristics of Adverse Events ____________________________________ 1

Event Types _____________________________________________________________ 1

Infections _______________________________________________________________ 3

Contributing Factors Identified in Reported Events ______________________________ 3

Levels of Harm in Reported Events ___________________________________________ 5

Characteristics of the Reports _______________________________________ 6

Number of Reports Submitted ______________________________________________ 6

Timeliness of Report Submission ____________________________________________ 7

Quality of Adverse Event Reports ____________________________________________ 8

Written Notification ______________________________________________________ 9

Conclusion _____________________________________________________ 10

Appendix I List of Reportable Events ________________________________ 11

Appendix II Contributing Factors ___________________________________ 12

Appendix III Criteria for Evaluation of Adverse Event Report Quality _______ 13


Figure 1. Over 98% of Oregon discharges are covered by hospitals participating in adverse

event reporting. ____________________________________________________________ v

Figure 2. Top Three Most Frequently Reported Events by Large, Medium, and Small

Hospitals _________________________________________________________________ 1

Figure 3. Reporting Trend by All Hospitals 2007-2010 ______________________________ 7

Table 1. Events Reported Events 2010 – All Hospitals ______________________________ 2

Table 2. Number and Percent of Infections Reported by Participating Hospitals _________ 3

Table 3. Proportion of Contributing Factors in Adverse Event Reports _________________ 4

Table 4. Ten Most Common Specific Factors Noted in Adverse Event Reports ___________ 4

Table 5. Event Type by Harm Level, for All Hospitals _______________________________ 5

Table 6. Level of Harm in Adverse Event Reports by Hospital Size ____________________ 6

Table 7. Number of Reports Submitted 2006-2010 ________________________________ 7

Table 8. Timeliness of Report Submission _______________________________________ 8

Table 9. Hospitals with Most Timely Submissions _________________________________ 8

Table 10. Comparison of Acceptability and Quality of Reports by Hospital Size __________ 9

Table 11. Written Notification Rates by Hospital Size ______________________________ 9

Table 12. Most Common Reasons for No Written Notification ______________________ 10

https://oregonpatientsafetyorg-1.sharepoint.microsoftonline.com/Hospital%20Newsletters/Hospital%20Summary%20Reports/Summary%202010%20ALL%205-5-11.docx#_Toc292978547





[v]

The Oregon Patient Safety Commission is charged with

fostering a culture of patient safety and decreasing the risk of

adverse events in Oregon. As part of that charge, the

Commission conducts a voluntary and confidential adverse

event reporting program for hospitals, nursing homes,

ambulatory surgery centers, and community/retail pharmacies.

The Commission promotes reporting as an act of transparency,

and supports safer care by collating information on events

across the state to identify risks and offer prevention strategies

through a non-regulatory external review process. The act of

reporting demonstrates to Oregon patients and their families that your organization is making a

commitment to safe care.

Oregon has 58 general acute care hospitals; 56 of those hospitals are signed participants in adverse

event reporting and cover over 98% of patient discharges in the state. These participating hospitals

have agreed to submit reports of serious adverse events in order to share information across the

state and prevent harm to other Oregon patients. The reporting program represents two key

aspects in Oregon’s North Star efforts: Learning from Experience and Patient/Family Engagement.

As the hospital arm of the program enters its sixth year, it has received 503 reports from hospitals

covering a range of event types and levels of harm. This summary of adverse events for calendar

year 2010 includes information on characteristics of adverse events reported by hospitals (types,

frequencies, harm levels, and contributing factors). We also describe characteristics of submitted

reports, (quantity, quality, and timeliness) as well as the extent to which hospitals provided written

notification to patients.

In 2010, the most frequently reported events overall were falls, unintentionally retained objects,

and pressure ulcers. We also received reports of unexpected deaths and delays in care, which may

indicate an increasing focus and attention on adverse events on the part of some hospitals. In

reporting events that are not as readily apparent as falls, for example, hospitals are demonstrating

an ability to identify more subtle adverse events.

Figure 1. Over 98% of Oregon discharges

are covered by hospitals participating in

adverse event reporting.


Page 1 of 13 Oregon Patient Safety Commission

0

2

4

6

8

10

12

Small Hospitals Medium Hospitals Large Hospitals

Number of

Events

Comparison of Proportion of Most Frequently Reported Events by Hospital Size

Fall Retention Ulcer

Characteristics of Adverse Events

Event Types

The 136 events reported in 2010 fall

into 30 event ‘types’: 18 were Never

Events chosen from the list on the

form, and 12 were Other Events,

defined by facilities themselves

upon reporting. Table 1 lists the

types of events reported and their

frequency.

The three most frequently reported

events regardless of hospital size1

were falls, unintentionally retained

objects, and pressure ulcers. Within

the Other category were varied

events related to surgery, such as

improper implants or lack of

required equipment. Together, surgical and procedural events account for nearly one-third of the

adverse events reported in 2010.

While large, medium, and small hospitals reported falls most frequently, the next most frequent events

differed by hospital size. For large hospitals, retained objects and pressure ulcers were second and third

in frequency. In medium hospitals retained objects and medication events were noted most frequently.

For small hospitals, injuries and unexpected death were the next most frequent after falls. That smaller

facilities perform fewer surgeries is a likely explanation for this difference.

Medication events were the fifth most frequent events, along with injuries, reported by hospitals of all

sizes. Nationally, reports have identified medication-related events as a common type of adverse event.

The Institute of Medicine (IOM) says that two of every 100 admissions result in “preventable adverse

drug event2.” Further, a study reported in the March 2011 issue of Health Affairs indicated that 38% of

identified events were medication related3. An explanation for the difference seen in Oregon reports is

1 The Commission uses annual discharges to determine hospital size. A large hospital has over 10,000 discharges a year, a medium hospital has between 3,001 and 10,000 discharges, and a small hospital has 3,000 or fewer discharges. 2 Kohn LT, Corrigan JM, Donaldson MS, editors. To Err Is Human: Building a Safer Health System. Washington (DC):

National Academies Press; 2000. 3 Classen DC, Resar R, Griffin R, Federico Frankel T, Kimmel N, et al. ‘Global Trigger Tool’ Shows That Adverse

Events In Hospitals May Be Ten Times Greater Than Previously Measured. Health Affairs, 2011; 30(4):581-89.

Figure 2. Top Three Most Frequently Reported Events by Large,

Medium, and Small Hospitals


April 2011 Page 2 of 13

less clear, though it may be related to an increased focus on adverse events that are more easily

identified or those for which reimbursement may be denied.

Table 1. Events Reported Events 2010 – All Hospitals

Large Medium Small All Hospitals

Type of Event # of

Events

% of

Events

# of

Events

% of

Events

# of

Events

% of

Events

# of

Events

% of

Events

Fall 7 10% 7 18% 8 31% 22 16%

Retained Object 11 15% 6 16% 1 4% 18 13%

Pressure Ulcer 8 11% 2 5% 1 4% 11 8%

Unexpected Death 5 7% 1 3% 3 12% 9 7%

Injury 2 3% 3 8% 3 12% 8 6%

Medication Event 2 3% 6 16% 8 6%

Healthcare Associated Infection 3 4% 4 11% 7 5%

Perinatal 6 8% 1 4% 7 5%

Equipment 2 3% 2 5% 2 8% 6 4%

Suicide 6 8% 6 4%

Care Delay 3 4% 2 8% 5 4%

Wrong Site Surgery 3 4% 2 5% 5 4%

Wrong Procedure 2 3% 1 3% 3 2%

Burn 2 3% 2 2%

Hypoglycemia 2 3% 2 2%

Perforation 1 1% 1 4% 2 2%

Wrong Patient 1 1% 1 3% 2 2%

Labor 1 1% 1 1%

Other 5 7% 3 8% 4 15% 12 9%

Total Events 72 38 26 136

Total Reports 66 35 24 125



Communication and

Policy/Procedure were

the most common

types of contributing

factors identified in

adverse event reports

Infections

The Commission has received few reports (n=7) of healthcare-associated infections (HAI) 5% of all

events -- despite state infection reporting data1 that shows 86 infections reported during the first half of

2010. The 37 hospitals submitting HAI adverse event reports in 2010 represent 86% of central line

associated bloodstream infections (CLABSI), and 73% of knee prosthesis surgical site infections (KPRO

SSIs).

Table 2. Number and Percent of Infections Reported by Participating Hospitals

Year Infection

All Large

Hospitals

n=11

All Medium

Hospitals

n=16

All Small

Hospitals*

n=29

All

Hospitals

n=56

CLABSI 60 (77%) 17 (22%) 1 (1%) 78

2009 KPRO SSI 34 (52%) 20 (30%) 12 (18%) 66

CBG SSI 52 (84%) 10 (16%) 0 (0%) 62

CLABSI 23 (82%) 5 (18%) 0 (0%) 28

Jan-Jun 2010 KPRO SSI 6 (27%) 13 (59%) 3 (14%) 22

CBG SSI 28 (78%) 8 (22%) 0 (0%) 36

*Excludes two small hospitals not participating in Oregon Patient Safety Commission

Contributing Factors Identified in Reported Events

Of the nine categories of contributing factors, two were seen the most

frequently across hospitals of all sizes: Communication and Policies &

Procedures (see Table 3). Communication-related contributing factors

were the most frequent, with 82 of the 125 reports (66%) noting some

type of communication difficulty as contributing to the adverse event.

Policies & Procedures were the next most frequent contributing factor

category overall, cited in 60% of reports. It was seen in the highest

proportion of reports from small hospitals (75%).

1 Data on infection rates from Oregon Health Policy and Research HAI Program 2009 and January – June 2010 (latest available)

See http://www.oregon.gov/OHPPR/HAI_Report.shtml

http://www.oregon.gov/OHPPR/HAI_Report.shtml



Table 3. Proportion of Contributing Factors in Adverse Event Reports*

Contributing Factor Large

Hospitals

n = 66

Medium

Hospitals

n = 35

Small

Hospitals

n = 24

All

Reports

n = 125

Communication 65.2% 65.7% 66.7% 65.6%

Policies Procedures 57.6% 57.1% 75.0% 60.8%

Patient Management 54.5% 45.7% 41.7% 49.6%

Training and Supervision 45.5% 34.3% 50.0% 44.8%

Equipment, Software, or Material Defects 40.9% 34.3% 33.3% 37.6%

Patient Factors 40.9% 34.3% 41.7% 39.2%

Work Area/Environment 37.9% 45.7% 37.5% 40.0%

Organizational Factors 34.8% 31.4% 45.8% 36.0%

*Percentages do not total 100% because multiple categories can be selected in each event report.

Each of the main Contributing Factor categories includes a number of specific sub-factors. The ten most

commonly indicated sub-factors are given in Table 4. In the top ten factors are two from the

Communication, Patient Factors, and Patient Management categories, and one each from the

Equipment, Policies & Procedures, and Training and Supervision categories. For a complete listing of

each Category with sub-factors, see Appendix II.

Table 4. Ten Most Common Specific Factors Noted in Adverse Event Reports

Large

Hospitals

n = 66

Medium

Hospitals

n = 35

Small

Hospitals

n = 24

All

Reports

n = 125

Communication — Among Hospital Personnel 29 13 13 55

Policies Procedures — Not Followed/Compliant 18 13 12 43

Communication — Hand-Offs/Shift Reports 23 5 9 37

Training And Supervision — In-Service Education/Competency 18 9 8 35

Patient Factors — Other 17 4 8 29

Patient Management — Response To Changing Condition 14 7 5 26

Equipment, Software, Or Material Defects — Other 15 6 4 25

Patient Factors — Mental Status 11 6 4 21

Work Area/Environment — Distractions 6 10 5 21

Patient Management — Care Plan 12 4 3 19



Perinatal events

were the most

frequently reported

event resulting in

death

Levels of Harm in Reported Events

Hospitals overall reported more serious1 harm events (81) than less

serious harm events (41). The most frequently reported serious harm

event were falls, followed by retained objects (see Table 5). Falls and

retained objects were the most frequently reported serious events,

followed by unexpected death and injury. Pressure ulcers, the third

most frequently reported event, more often resulted in moderate harm.

Table 5. Event Type by Harm Level, for All Hospitals

Type of Event No Harm

(1-2)

Low Harm

(3-4)

Moderate

Harm (5-6)

Serious

Harm (7-9)

Fall 3 1 2 16

Retained Object 1 3 3 11

Pressure Ulcer 7 4

Unexpected Death 9

Medication Event 1 1 6

Healthcare Associated Infection 1 6

Perinatal 7

Equipment 3 1 2

Suicide 6

Wrong site surgery 1 1 3

Injury 8

Care Delay 1 4

Wrong procedure 1 1 1

Burn 1 1

Hypoglycemia 2

Perforation 2

Labor 1

Wrong patient 1 1

Other 2 6

Total Events 15 7 21 93

Total Reports 15 6 20 84

1 Serious events are those resulting in harm levels of 7, 8, or 9 and six specific types of events that are considered serious,

regardless of harm. (Infant discharged to the wrong person, wrong gas given to a person, wrong procedure performed, wrong site surgery/procedure, procedure on wrong person, and retained object.) See Appendix 1 for listing of reportable events.



REPORTING ACTIVITY DROPS

The 125 reports submitted in 2010

represent a leveling off in reporting

from 2009 and a significant decline

in the rate of increase from the

2007 to 2009 rates. The number of

hospitals reporting events also

declined in 2010.

Serious events are required reports; however, the Commission encourages reporting of less serious

events (both required and non-required or “additional” reports) in order to develop deeper

understandings. As noted in Table 6, large facilities reported the largest number of less serious harm

events. Overall, medium and small facility groups each submitted 12 such reports; however, small

hospitals submitted a higher proportion of “additional” lower harm events (as compared to required

lower harm events) than did medium facilities. Small facilities reported the smallest number of required

events, and the smallest number of serious harm events.

Table 6. Level of Harm in Adverse Event Reports by Hospital Size

Large Medium Small ALL

Less Serious Harm 17 12 12 41

Required 9 6 1 16

Additional 8 6 11 25

Serious Harm 49 23 12 84

TOTAL 66 35 24 125

Characteristics of the Reports

Number of Reports Submitted

Oregon hospitals submitted 125 adverse event reports

in 2010, the same number as were submitted in 2009.

The 37 hospitals that submitted adverse event reports

in 2010 represent 86% of OR discharges and 85% of

inpatient surgeries. The large facilities that reported in

2010 represent 60% of Oregon discharges; medium

facilities represent 21% and small facilities 4.8%. They

account for 53%, 28%, and 19% of all reported events,

respectively.

While the number of hospitals submitting reports in 2010

increased slightly, the overall number of submissions remained static from 2009. Table 7 gives the

number of reports submitted each year of the program.



Table 7. Number of Reports Submitted 2006-2010

2006 2007 2008 2009 2010 Total

Large 23 55 67 72 66 283

Medium 12 19 28 28 35 122

Small 18 11 23 25 24 101

Total 53 85 118 125 125 506

Reporting activity, as noted in the chart below, shows a marked increase from 2007 to 2008 with a slight

increase in 2009 and no increase in 2010. Based on the 2008 to 2009 increase, we expected to see 136

reports in 2010. The more recent trend line, based on the annual number of reports since 2007, projects

145 reports for 2011 and 156 for 2012. This is still well below what might be expected based on

literature published in the past several years.

Figure 3. Reporting Trend by All Hospitals 2007-2010

Timeliness of Report Submission

Memories fade quickly after an adverse event, requiring an

immediate response to collect full and reliable information on

the circumstances surrounding the event. The goal for

submission of an adverse event report is 45 days following

discovery of the event.

0

40

80

120

160

2007 2008 2009 2010

Trend in Number of Adverse Event Reports Submitted

MILESTONES IN ADVERSE

EVENT INVESTIGATION

*Discovery of the Event

*Event Investigation

*Investigation & Review

Completed

*Submission of Report



The average event to submission time for all facilities in 2010 was 103 days (over three months). The

median days from event to submission was 62 days in 2009 (about two months) and 79 days in 2010

(about two and a half months). While hospitals reduced their previous average event to QM notification

time in 2010, they increased their review completion to submission time. In Table 8, three significant

time periods are shown: days between occurrence of the adverse event and notification of Quality

Management; days between notification and completion of the event review; and days between

completion of the review and submission to the Commission.

Table 8. Timeliness of Report Submission

(all values in days)

Event to

Quality

Management*

QM to Review

Completed

Review

Completed to

Submission

2009-2010 (n=242) 10.6 37.0 55.6

2009 (n=124) 11.5 36.9 49.1

2010 (n=122) 9.8 37.2 62.2

*may be lengthened in cases where events were discovered on chart review

Nine facilities were close to meeting, or did meet, the 45-day reporting goal in 2010. Two of the large

hospitals, two medium hospitals, and five small were the most timely reporters. While there is no

absolute rule regarding the time required to fully investigate and review an adverse event, a very short

turnaround time may indicate a less than thorough investigation.

Table 9. Hospitals with Most Timely Submissions

Hospital*

L01 L06 M24 M21 S15 S07 S18 S14 S06

Days

48.9 59.0 42.6 46.5 9.4 14.5 19.0 33.5 54.5

*Hospitals are designated by size, for example L indicates a large hospital and the number reflects a confidential

code used for program summaries.

Quality of Adverse Event Reports

The Commission reviews submitted reports and determines

whether they have met criteria for acceptability. The criteria are

based upon the four Joint Commission Criteria. A report is Complete

if it contains all of the information requested in the event report, or

explains to the Commission’s satisfaction why that information is

not available or not necessary to provide. A report is Thorough if

the root cause analysis includes an analysis of all relevant systems

issues and shows evidence of an inquiry into all appropriate areas. A

QUALITY CRITERIA

*Complete

*Thorough

*Credible

*Meaningful Action Plans



report is Credible if it shows evidence that the investigation included leadership participation and was

internally consistent. Meaningful action plans clearly describe improvement strategies designed to

minimize risk. If all criteria are met, the report is considered Acceptable.

As part of their mandate for review of the Commission, the Public Health Officer also reviews reports

using the same criteria, and evaluates how well each report met the criteria, which identifies reports

that exceed the minimum criteria and are of high quality. See Appendix III for a description of the

criteria and how they are used to evaluate reports.

Hospitals submitted mostly acceptable, high quality reports in 2010. Overall, 91% were acceptable and

85% were high quality (see Table 10).

Table 10. Comparison of Acceptability and Quality of Reports by Hospital Size

Number of

Reports

Number

Acceptable

Num. High

Quality

% High

Quality

Large Hospitals 66 61 58 88%

Medium Hospitals 35 32 30 86%

Small Hospitals 24 21 19 78%

All OR Hospitals 125 114 107 85%

Written Notification

Written notification of an adverse event to the patient or family member is required for all serious

events with a harm level of 7, 8, or 9. The requirement only states that the notification be consistent

with internal communication policies of the hospital and that it be timely. Recognizing the significant

difficulty many hospitals have had in meeting this requirement, the Commission is developing resources

and tools to assist hospitals.

While this is a difficult requirement, nine hospitals always provided it, four have provided it most of the

time and 17 facilities never provided written notification. In some circumstances the patient does not

have anyone to notify, or attempts to notify have failed (such as return of the notification, unopened).

In calculating completion of written notification, the Commission considers such circumstances.

Table 11. Written Notification Rates by Hospital Size

Number of

Facilities

Number of

Notifications

Completed

Number

Required

%

Large Hospitals 9 29 45 64%

Medium Hospitals 10 3 23 13%

Small Hospitals 11 4 12 33%

All OR Hospitals 30 36 80 45%



When a reason for not providing written notification was stated on the report, the most common reason

given was that verbal disclosure was done, followed closely by no policy in place and “other.”

Table 12. Most Common Reasons for No Written Notification

Verbal

Disclosure No Policy

Lack of

Support

Patient

Transferred

No

Reason

Given

Other*

Large Hospitals 4 6 1 5

Medium Hospitals 10 3 1 1 1 4

Small Hospitals 3 2 3

All OR Hospitals 17 11 1 1 2 12

*Other Reasons for not Providing Written Notification: No contact information for patient No family (for diseased patient) Patient status (mental status, home life, imminent threat of danger, etc., usually at clinician’s request) Retrospective (too much time has passed)

Conclusion

This report has summarized the adverse events reported by Oregon hospitals in 2010. The reports

represented a variety of event types and harm levels that occur each year. There was a slight increase in

the number of hospitals reporting adverse events, but no increase from the previous year in the

numbers of events reported. This level of reporting activity will not provide for a strong database from

which to identify specific factors to address and successful strategies for eliminating risk.

Based upon our review, we believe that there is much opportunity for enhanced understanding of

adverse events, their contributing factors, and underlying or root causes through increased reporting.

Two areas in particular -- healthcare associated infection and medication events -- would benefit from a

greater number of reports being submitted. Increased reporting of these types of events will also begin

to allow for identification of patterns across event types.

Adverse event reporting offers several ways to quantify gains in the sometimes imprecise concept of

culture of safety:

Growth in identification, investigation, and reporting of events;

Responsiveness to adverse events in a timely manner;

Recognition of more subtle adverse events; Improvements in written notification.

Hospital feedback and active engagement will, we believe, significantly accelerate the development of a

robust statewide culture of patient safety. The Commission is pleased to partner with Oregon hospitals

in this vital work.



Appendix I List of Reportable Events1

1. GENERAL CATEGORY Any unanticipated, usually preventable consequence of patient care that results in patient death or serious physical injury. 2. SURGICAL EVENTS A. Surgery performed on the wrong body part. B. Surgery performed on the wrong patient. C. Wrong surgical procedure performed on a patient. D. Retention of a foreign object in a patient after surgery or other procedure. E. Intraoperative or immediately post-operative death in an ASA Class I patient. 3. PRODUCT OR DEVICE EVENTS A. Patient death or serious physical injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility. B. Patient death or serious physical injury associated with the use or function of a device in patient care in which the device is used or functions other than as intended or is difficult to use as intended. C. Patient death or serious physical injury associated with intravascular air embolism that occurs while being cared for in a healthcare facility. 4. PATIENT PROTECTION EVENTS A. Infant discharged to the wrong person B. Patient death/serious physical injury associated with patient elopement (disappearance) for over four hours. C. Patient suicide/ attempted suicide resulting in serious physical injury while being cared for in a healthcare facility. 5. CARE MANAGEMENT EVENTS A. Patient death or serious physical injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration). B. Patient death or serious physical injury associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products. C. Maternal death or serious physical injury associated with labor or delivery in a low-risk pregnancy. D. Patient death or serious physical injury associated with hypoglycemia. E. Death or serious physical injury (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates. F. Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility. G. Patient death or serious physical injury due to spinal manipulative therapy. H. Any perinatal death or serious physical injury unrelated to a congenital condition in an infant having a birth weight greater than 2500 grams. 6. ENVIRONMENTAL EVENTS A. Patient death or serious physical injury associated with an electric shock while being cared for in a healthcare facility. B. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances. C. Patient death or serious physical injury associated with a burn incurred from any source while being cared for in a healthcare facility. D. Patient death or serious physical injury associated with a fall while being cared for in a healthcare facility. E. Patient death or serious physical injury associated with the use of restraints or bedrails while being cared for in a healthcare facility.

1From the National Quality Foundation’s list of ‘Never’ events and a General category that includes other events

resulting in serious harm. See Administrative Rules Chapter 35 Division 10, Appendix A -- Oregon Patient Safety Reporting Program for Hospitals.

http://arcweb.sos.state.or.us/rules/OARs_300/OAR_325/325_010.html



Appendix II Contributing Factors

Communications: Hand-offs or shift reports Available information Between staff & patient/family Hard to read handwriting/fax Among staff Look-alike/sound-alike drug Other (please describe):

Training and Supervision: Job orientation In-service education/competency training Staff supervision Routine job training Availability of training programs Other (please describe):

Patient Factors: Language/culture Family dynamics/relationships Mental status Behavioral status Other (please describe):

Policies, Procedures: Absent Too complicated Outdated Not followed/compliant Other (please describe):

Technology/Equipment: Equipment meeting code, specifications, or regulations

Electronic Medical Records (EMR) Defective/non-working equipment

Automated dispensing (e.g., Pyxis) Equipment design (function, displays, or controls) Electronic prescribing (CPOE) Medication admin checking (e.g., MAK) Other (please describe): Software (please list):

Work Area/Environment: Work area design and specifications Distractions Lighting Noise Relief/float healthcare staff Interruptions (please describe): Other (please describe)

Organizational Factors: Overall culture of safety Staffing levels Leadership/management Adequacy of budget Systems to identify risks Internal reporting Staff assignment/work allocation Other (please describe):

Patient management: Delegation of clinical care Response to changing condition Patient consent process Care plan Initial diagnosis Tracking or follow-up Two or more prescriptions filled at same time

Other (please describe)



Appendix III Criteria for Evaluation of Adverse Event Report Quality

Criteria for evaluation of adverse event report quality closely follow the Joint Commission’s criteria* and

are consistent with criteria used by the Public Health Officer in preparing annual certification reports. In

evaluating a report we recognize that there are limitations in the reporting form’s ability to capture fully

information and the difficulty in summarizing hours of investigation and analysis into a few pages. How

the criteria are applied to a specific event report is noted below. Measure/s refers to how the

information is judged as meeting the criterion (that is, what is looked for); Point Allocation refers to the

number of points given for each criterion in order to identify particularly high quality reports. In addition

to allocating points for each criterion, the Commission evaluates the overall acceptability of the report,

which requires that each criterion receive a minimum of one point.

Criteria (points possible)

Definition OAR 325-010-0035 (1)a-d

Measure/s Point

Allocation

COMPLETE (2)

Contains all information requested in the Event report, or explains to the Commission's satisfaction why that information is not available or not necessary to provide

Event Description explains the event by including the sequence of actions and relevant environmental conditions in the description in addition to relevant clinical information

Event Description

(0/1/2)

THOROUGH (3)

Includes analysis of all relevant systems issues and shows evidence of an inquiry into all appropriate areas

Primarily identify system-level contributing factors most directly associated with the event

Analysis (0/1)

At least one relevant root cause identified; presence of additional root or proximal causes

Analysis (0/1/2)

CREDIBLE (2)

Shows evidence that the investigation of the event included participation by leadership within the organization and was internally consistent

Notification (for serious events) of at least one of the following: administrator, senior management, leader on review team, or post-review briefing

Analysis (0/1)

Number of inconsistencies and/or contradictions among the sections: more than three inconsistencies = 0 points

Analysis (0/1)

ACTION PLANS (3)

Action plans clearly describe meaningful improvement strategies designed to minimize risk

Emphasize strong and system-level solutions that would decrease the likelihood of such events in the future

Action Plans (0/1/2)

Action plans address the identified causes/findings

(0/1)

* Joint Commission on Accreditation of Health Care Organization’s Sentinel Event Policy and Procedures, June 2005

based on the VA National Center for Patient Safety description of the strength of actions plans

November 2008; rev August 2009

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Summary Hospital Adverse Event Reports - Oregon State Library

Documents